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ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis
NCT05878860 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).
Conditions Studied
Interventions
- BIOLOGICAL ATSN-201
Study Locations (4)
California
- Children's Hospital of Los Angeles — Los Angeles
Florida
- Bascom Palmer Eye Institute — Miami
Oregon
- Oregon Health Sciences University — Portland
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2029-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05878860
The ClinicalTrials.gov registry entry for NCT05878860 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atsena Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with X-linked Retinoschisis appearing as the primary indexed condition, and to 1 intervention — of which ATSN-201 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05878860 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05878860 about?
NCT05878860 is a clinical study titled "ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis". This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).
What is the current status of trial NCT05878860?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2023-08-22. Estimated completion is 2029-10.
What conditions does trial NCT05878860 study?
This clinical trial studies the following conditions: X-linked Retinoschisis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05878860?
The interventions under investigation include: ATSN-201 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05878860?
This trial is sponsored by Atsena Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05878860 being conducted?
This trial has 4 study locations across California, Florida, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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